GENERIC NAME OF MEDICINAL PRODUCT:

A. Bupivacaine Hydrochloride Injection I.P. 0.25%
B. Bupivacaine Hydrochloride Injection I.P. 0.5%

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Bupivacaine Hydrochloride Injection IP 0.25%
Each ml contains:
Bupivacaine Hydrochloride I.P.
Equivalent to Anhydrous
Bupivacaine Hydrochloride…………..2.5mg
Sodium Chloride I.P. …………………….8.0mg
Water for Injections I.P. ……………….q.s
*No Preservative added

B. Bupivacaine Hydrochloride Injection I.P. 0.5%
Each ml contains:
Bupivacaine Hydrochloride I.P.
Equivalent to Anhydrous
Bupivacaine Hydrochloride…………..5.0mg
Sodium Chloride I.P. …………………….8.0mg
Methylparaben I.P. (as preservative)…..1.0mg
Water for Injections I.P. ………………..q.s


THERAPEUTIC INDICATION:

Bupivacaine injection is used to numb an area of your body during or after surgery or other procedures, childbirth, or dental work. This medicine is also used to numb your shoulder after surgery for up to 72 hours.

DIRECTION OF USE:

Bupivacaine Hydrochloride Injection given in the form of an epidural injection at the spinal cord.
A healthcare professional will administer the Bupivacaine Hydrochloride Injection, do not self-administer.

CAUTION AND SCHEDULE:

CAUTION: Do not use if any foreign particulate matter is visible.
To be administered after a test dose with adequate precaution to cope with any adverse reaction.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE: SCHEDULE 'H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store below 20 to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) Protect from light. .
DOSAGE: As directed by the Physician. .

Bupivacaine Hydrochloride Injection IP 0.5% Technical Specification:

Product Name:Bupivacaine Hydrochloride Injection I.P.
Brand Name:Generic
Strength:0.25%, 0.5%
Dosage Form:Liquid Injection
Packing:0.25% (20ml Single Use Vial)
0.5% (20ml Multiple Use Vial)
Route of Administration:Epidural injection at the spinal cord
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Local Anesthetic
Indication: Bupivacaine injection is used to numb an area of your body during or after surgery or other procedures, childbirth, or dental work. This medicine is also used to numb your shoulder after surgery for up to 72 hours.
Storage:Store below 20 to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).Protect from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Bupivacaine Hydrochloride Injection I.P. 0.5%

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Bupivacaine Hydrochloride Injection IP 0.5%
    Each ml contains:
    Bupivacaine Hydrochloride I.P.
    Equivalent to Anhydrous
    Bupivacaine Hydrochloride…………..5.0mg
    Sodium Chloride I.P. …………………….8.0mg
    Methylparaben I.P. (as preservative)…..1.0mg
    Water for Injections I.P. ……………….q.s

THERAPEUTIC INDICATION:

Bupivacaine injection is used to numb an area of your body during or after surgery or other procedures, childbirth, or dental work. This medicine is also used to numb your shoulder after surgery for up to 72 hours.

DIRECTION OF USE:

Bupivacaine Hydrochloride Injection given in the form of an epidural injection at the spinal cord.
A healthcare professional will administer the Bupivacaine Hydrochloride Injection, do not self-administer.

CAUTION AND SCHEDULE:

CAUTION: Do not use if it is turbid or contains particles or suspended matters.
To be administered after a test dose with adequate precaution to cope with any adverse reaction.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

SCHEDULE: SCHEDULE ‘H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store below 20 to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.

DOSAGE: As directed by the Physician.